Decloaking Chamber™ NxGen Reconditioned

GUDID 00847627023520

BIOCARE MEDICAL LLC

Pressurized incubator IVD

• Primary Device ID: 00847627023520
• NIH Device Record Key: 50b78249-d44a-43a6-90ca-16c6e75b63e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Decloaking Chamber™ NxGen Reconditioned
• Version Model Number: DC2012-220V-R
• Company DUNS: 806617825
• Company Name: BIOCARE MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627023520 [Primary]

FDA Product Code

• KPA: Slide Stainer, Automated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Decloaking Chamber™ NxGen Reconditioned]

• 00847627023537: DC2012-R
• 00847627023520: DC2012-220V-R